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Clinical Trials/NCT05863143
NCT05863143
Completed
N/A

Effectiveness of Nutritional and Exercise Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor

Universiti Putra Malaysia1 site in 1 country100 target enrollmentOctober 23, 2022
ConditionsFall

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fall
Sponsor
Universiti Putra Malaysia
Enrollment
100
Locations
1
Primary Endpoint
Mean Changes in Risk of Falls
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Falls is a major concern in geriatrics due to its high prevalence and various adverse health complications among elderly population. Risk of falls can be reduced by improving nutritional status and increase the level of physical activity. Besides, knowledge regarding risk of falls, nutrition and exercise are important in reducing the risks of falls. Therefore, this study aims to develop, implement and evaluate the effectiveness of a nutritional education and exercise intervention among community dwelling older adults in Selangor.

Detailed Description

General Objective: To develop, implement and evaluate the effectiveness of nutrition education and exercise intervention on risk of fall among older person in Selangor. Specific Objectives: * To determine the risk of falls among the older adults. * To determine the dietary intake, anthropometric parameters (body mass index, mid upper arm circumference, calf circumference, body fat percentage and skeletal muscle mass), nutritional status, level of physical activity, functional status, perceived quality of life, risk of sarcopenia, level of knowledge, attitude and practice (KAP) towards falls' risk reduction, nutrition and exercise among the older adults. * To identify the factors determining risk of falls among older adults. * To evaluate the implementation process of the nutrition education and exercise intervention program (attendance and feedback of the program). * To determine the mean differences in risk of falls, dietary intake, anthropometric parameters, nutritional status, physical activity, functional status, perceived quality of life, risk of sarcopenia and knowledge, attitude and practice (KAP) towards falls' risks reduction, nutrition and exercise between intervention and control groups before and after intervention. The proposed study location is in Selangor. This is a randomized wait-list controlled trial for 3 months (12 weeks) among community dwelling older adults in Selangor. A two-stage sampling design will be applied. Firstly, a random sampling will be applied to select two districts from Selangor. This is followed by a purposive sampling to recruit eligible subjects according to inclusion criteria. Subjects will be recruited from free living older adults residing in Selangor through various community settings including including affiliations of National Council of Senior Citizens Organisations Malaysia (NACSCOM), University of Third Age (U3A) and Alzheimer's Disease Foundation Malaysia (ADFM). Subjects will be allocated randomly into 2 groups: Group 1: Intervention group (nutrition education + exercise intervention) Group 2: Control group (no intervention) which total of 100 eligible subjects will be recruited, with 50 subjects are needed in respective groups. This study will use a set of questionnaires to obtain information on personal information, anthropometry data, nutritional status, level of physical activity, functional status, sleep quality, quality of life, risk of falls, risk of sarcopenia and KAP on falls' risk reduction, nutrition and exercise based on appropriate instruments. Assessments will be performed at baseline (week 0), mid-way (week 6) and post-intervention (after week 12).

Registry
clinicaltrials.gov
Start Date
October 23, 2022
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chan Yoke Mun

Professor

Universiti Putra Malaysia

Eligibility Criteria

Inclusion Criteria

  • Men or women aged 60 years old to 80 years old in Malaysia
  • Able to ambulate without personal assistance
  • Able to read and write

Exclusion Criteria

  • Self-reported chronic diseases (severely poorly control diabetics and hyperlipidemia, heart-related disease, Chronic obstructive pulmonary disease, osteoarthritis, osteoporosis, stroke, cancer, asthma, renal dysfunction, terminally ill that may limit participations in physical activity)
  • Any sustained fracture or undergoing surgery (hip, vertebrata) in past six months
  • Bedridden
  • Sensory impairment (visual \& hearing) that will interfere with communication
  • Anyone who participated in similar program before

Outcomes

Primary Outcomes

Mean Changes in Risk of Falls

Time Frame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

Besides assessing risk of falls using Timed Up and Go (TUG) test and Five Times Sit to Stand Test, risk of falls of the respondents will be determined using 30 Second Sit to Stand Test (30CST). For 30 Second Sit to Stand Test, respondents are required to sit straight on a chair with arms are crossed at the wrists and held in front of the chest. The respondents are encouraged to complete as many full stands as possible within 30 seconds.

Secondary Outcomes

  • Mean Changes in Skeletal Muscle Mass(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Weight(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Gait Speed(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Height(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in calf-circumference(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Vitamin D Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Nutritional Status(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Functional Status(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Handgrip Strength(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Protein Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Calcium Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Sleep Quality(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Energy Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Physical Activity Level(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
  • Mean Changes in Knowledge, Attitude and Practice on Falls' risk reduction, nutrition and exercise Questionnaire(Assessments will be performed at Baseline (Week 0) and Post-Intervention (Week 12))
  • Mean Changes in Quality of Life(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))

Study Sites (1)

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